"The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.
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Xifaxan Side Effects Center
Pharmacy Editor: Charles Patrick Davis, MD, PhD
Xifaxan (rifaximin) is an antibiotic indicated for the treatment of patients 12 years of age and older with travelers' diarrhea caused by noninvasive strains of Escherichia coli (E. coli), and to lower the risk of worsened brain function, or hepatic encephalopathy, in adults with liver failure. Side effects of Xifaxan include nausea, vomiting, constipation, bloating, gas, stomach pain, feeling like you need to urgently empty your bowel, feeling your bowel is not completely empty, headache, dizziness, tired feeling, or swelling in your hands, feet, or torso.
Xifaxan (rifaximin) tablets for oral administration are film-coated and contain 200 or 550 mg of rifaximin. Usual dosage is 200 mg three times a day for three days for diarrhea and 550mg twice a day for 3 days for hepatic encephalopathy. Serious side effects include C. difficile diarrhea and continued diarrhea due to organisms resistant to the drug. Caution is suggested when treating severe hepatic encephalopathy as systemic drug toxicity may develop. There are no adequate and well controlled studies of Xifaxan use in pregnancy; the drug should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. It is not known if the drug is present in breast milk. The safety and effectiveness of Xifaxan in pediatric patients with travelers' diarrhea less than 12 years of age have not been established.
Our Xifaxan Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Xifaxan in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using rifaximin and call your doctor at once if you have a fever or diarrhea that is watery or bloody.
Less serious side effects are more likely, and may include:
- bloating, gas, stomach pain;
- feeling like you need to empty your bowel urgently;
- feeling like your bowel is not completely empty;
- nausea, vomiting, constipation;
- headache, dizziness;
- tired feeling; or
- swelling in your hands, feet, or torso.
Read the entire detailed patient monograph for Xifaxan (Rifaximin)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Xifaxan Overview - Patient Information: Side Effects
This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.
Do not use anti-diarrhea products or narcotic pain medications if you have any of these symptoms because these products may make them worse.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Xifaxan (Rifaximin)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Xifaxan FDA Prescribing Information: Side Effects
Clinical Studies Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of XIFAXAN 200 mg taken three times a day was evaluated in patients with travelers' diarrhea consisting of 320 patients in two placebo-controlled clinical trials with 95% of patients receiving three or four days of treatment with XIFAXAN. The population studied had a mean age of 31.3 (18-79) years of which approximately 3% were ≥ 65 years old, 53% were male and 84% were White, 11% were Hispanic.
Discontinuations due to adverse reactions occurred in 0.4% of patients. The adverse reactions leading to discontinuation were taste loss, dysentery, weight decrease, anorexia, nausea and nasal passage irritation.
The adverse reaction that occurred at a frequency ≥ 2% in XIFAXAN-treated patients (n=320) at a higher rate than placebo (n=228) in the two placebo-controlled trials of TD was:
- headache (10% XIFAXAN, 9% placebo)
The data described below reflect exposure to XIFAXAN in 348 patients, including 265 exposed for 6 months and 202 exposed for more than a year (mean exposure was 364 days).
The safety of XIFAXAN 550 mg taken two times a day for reducing the risk of overt hepatic encephalopathy recurrence in adult patients was evaluated in a 6-month placebo-controlled clinical trial (n=140) and in a long term follow-up study (n=280). The population studied had a mean age of 56 (range: 21 to 82) years; approximately 20% of the patients were ≥ 65 years old, 61% were male, 86% were White, and 4% were Black. Ninety-one percent of patients in the trial were taking lactulose concomitantly. The most common adverse reactions that occurred at an incidence ≥ 5% and at a higher incidence in XIFAXAN-treated subjects than in the placebo group in the 6-month trial are provided in Table 1.
Table 1: Most Common Adverse
Reactions* in HE Trial
|MedDRA Preferred Term||Number (%) of Patients|
|XIFAXAN Tablets 550 mg TWICE DAILY
|Peripheral edema||21 (15%)||13 (8%)|
|Nausea||20 (14%)||21 (13%)|
|Dizziness||18 (13%)||13 (8%)|
|Fatigue||17 (12%)||18 (11%)|
|Ascites||16 (11%)||15 (9%)|
|Muscle spasms||13 (9%)||11 (7%)|
|Pruritus||13 (9%)||10 (6%)|
|Abdominal pain||12 (9%)||13 (8%)|
|Anemia||11 (8%)||6 (4%)|
|Depression||10 (7%)||8 (5%)|
|Nasopharyngitis||10 (7%)||10 (6%)|
|Abdominal pain upper||9 (6%)||8 (5%)|
|Arthralgia||9 (6%)||4 (3%)|
|Dyspnea||9 (6%)||7 (4%)|
|Pyrexia||9 (6%)||5 (3%)|
|Rash||7 (5%)||6 (4%)|
|* reported in ≥ 5% of Patients Receiving XIFAXAN and at a higher incidence than placebo|
Irritable Bowel Syndrome with Diarrhea
The safety of XIFAXAN for the treatment of IBS-D was evaluated in 3 placebo-controlled studies in which 952 patients were randomized to XIFAXAN 550 mg three times a day for 14 days. Across the 3 studies, 96% of patients received at least 14 days of treatment with XIFAXAN. In Trials 1 and 2, 624 patients received only one 14-day treatment. Trial 3 evaluated the safety of XIFAXAN in 328 patients who received 1 open-label treatment and 2 double-blind repeat treatments of 14 days each over a period of up to 46 weeks. The combined population studied had a mean age of 47 (range: 18 to 88) years of whom approximately 11% of the patients were ≥ 65 years old, 72% were female, 88% were White, 9% were Black and 12% were Hispanic.
The adverse reaction that occurred at a frequency ≥ 2% in XIFAXAN-treated patients at a higher rate than placebo in Trials 1 and 2 for IBS-D was:
- nausea (3% XIFAXAN, 2% placebo)
The adverse reactions that occurred at a frequency ≥ 2% in XIFAXAN-treated patients (n=328) at a higher rate than placebo (n=308) in Trial 3 for IBS-D during the double-blind treatment phase were:
- ALT increased (XIFAXAN 2%, placebo 1%)
- nausea (XIFAXAN 2%, placebo 1%)
Less Common Adverse Reactions
The following adverse reactions, presented by body system, were reported in less than 2% of patients in clinical trials of TD and IBS-D and in less than 5% of patients in clinical trials of HE:
Investigations: Increased blood creatine phosphokinase
Musculoskeletal and connective tissue disorders: myalgia
The following adverse reactions have been identified during post-approval use of XIFAXAN. Because these reactions are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These reactions have been chosen for inclusion due to either their seriousness, frequency of reporting or causal connection to XIFAXAN.
Infections and Infestations
Hypersensitivity reactions, including exfoliative dermatitis, rash, angioneurotic edema (swelling of face and tongue and difficulty swallowing), urticaria, flushing, pruritus and anaphylaxis have been reported. These events occurred as early as within 15 minutes of drug administration.
Read the entire FDA prescribing information for Xifaxan (Rifaximin)
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